Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
Cardinal Health is recalling 602 Presource surgical kits because they contain MEDICOM Ritmed Neurological Sponges with unexpected endotoxin variability.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a contamination hazard (endotoxin variability) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a high-risk product where harm has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling 602 Presource surgical kits, including Septo Rhino, Neuro Minor Craniotomy, Neuro Major 2, Neuro, Laminectomy, Pedi Spine, Shunt, and Ortho Fusion kits. The recall is due to the inclusion of MEDICOM Ritmed Neurological Sponges that were previously recalled for unexpected variability in endotoxin levels.
The affected products were distributed nationwide in the United States and in Canada. Specific lot numbers and UDI-DI codes for the 11 affected catalog numbers are available in the structured product information.
Healthcare facilities and consumers should stop using these kits and contact Cardinal Health for further instructions or a return.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 602
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) SEN73NSKCF
- UDI-DI: 10888439509304(each)
- 50888439509302(case)
- Lot Number: 3024-2
- 2) SNE30CNOHE
- UDI-DI: 10195594506230(each)
- 50195594506238(case)
- Lot Number: 93845
- 3) SNE30CRJGY
- UDI-DI: 10195594453992(each)
- 50195594453990(case)
- Lot Number: 4730
- 4) SNE43NEE13
- UDI-DI: 10198956470965(each)
- 50198956470963(case)
- Lot Number: 14039
- 5) SNE5CLPB12
- UDI-DI: 10197106266687(each)
- 50197106266685(case)
- Lot Number: 6033
Distribution
Distributed nationwide across the United States.
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